{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Broomfield",
      "state": "CO",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA078692"
        ],
        "brand_name": [
          "CETIRIZINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "CETIRIZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Sandoz Inc"
        ],
        "product_ndc": [
          "0781-5283"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CETIRIZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1014643"
        ],
        "spl_id": [
          "973d0d70-f69f-44b6-98f0-f436e63bd15a"
        ],
        "spl_set_id": [
          "817d07cf-5e31-421f-9e95-943bae01f5b0"
        ],
        "package_ndc": [
          "0781-5283-06",
          "0781-5283-64",
          "0904-5878-33"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0307815283643"
        ],
        "unii": [
          "64O047KTOA"
        ]
      },
      "product_type": "Drugs",
      "event_id": "63224",
      "recalling_firm": "Sandoz Incorporated",
      "address_1": "2555 W Midway Blvd",
      "address_2": "N/A",
      "postal_code": "80020-1632",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-008-2013",
      "product_description": "Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ NDC 0781-5283-64 --- ALSO sold under  Major brand All Day Allergy Children's Cetirizine HCl 5 mg, 5 count blister pack, Major Pharmaceuticals, Livonia, MI NDC 0904-5878-33",
      "product_quantity": "67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons",
      "reason_for_recall": "Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)",
      "recall_initiation_date": "20120920",
      "center_classification_date": "20121018",
      "termination_date": "20130114",
      "report_date": "20121024",
      "code_info": "NDC 0781-5283-64 lots: BT2862, BT7986, BT7994, BW0652, CC1961, and CA3437; NDC 0904-5878-33 lot BW0665."
    }
  ]
}